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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA INVACARE(R) PERFECTO2(TM) OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA INVACARE(R) PERFECTO2(TM) OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number NA:IRC5P
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Death  
Manufacturer Narrative

This medwatch is being filed out of an abundance of caution. There is no alleged failure of the device. Invacare attempted to obtain further information without success. The patient¿s medical history, reason for requiring supplemental oxygen or what caused the death are unknown. The concentrator and home-fill were delivered to the patient on 2-25-20. According to the patient¿s boyfriend, the patient only used the equipment for a day or so before being admitted to the icu. The patient refused to have back-up oxygen and had signed a waiver stating such. Due to the possible pneumonia diagnosis the dealer placed the concentrator in quarantine. The concentrator will not be returned at this time. This concentrator was manufactured by invacare (b)(4). However, they are no longer in business. The manufacturer of these concentrators has since been transitioned to invacare (b)(4). Therefore, the mdr is being filed under invacare (b)(4).

 
Event Description

Invacare was made aware of the death of a consumer who was using an irc5p concentrator. There is no alleged failure of the device however, the family insists the device potentially contributed to the patients' acute respiratory failure, pneumonia, and subsequent death.

 
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Brand NameINVACARE(R) PERFECTO2(TM) OXYGEN CONCENTRATOR
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
INVACARE FLORIDA
2101 east lake mary blvd
sanford FL 32773
Manufacturer (Section G)
INVACARE FLORIDA
2101 east lake mary blvd
sanford FL 32773
Manufacturer Contact
jason fiest
one invacare way
elyria , OH 44036
8003336900
MDR Report Key9959197
Report Number1031452-2020-00011
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2020
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberNA:IRC5P
Device Catalogue NumberIRC5P
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/03/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/14/2020 Patient Sequence Number: 1
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